Recall archive
88 recalls · page 2 of 4
Reported Apr 25, 2018
Teleflex MEDICAL HUDSON RCI One Way Valve w. Capped Monitoring Port, REF 1644, QTY 50 Product Usage: for use in…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Teleflex Medical Europe Ltd.
Matched: Brand · Product · Product details — These one-way valves may disconnect at the joint between the two components that make up the device, which would cause an interruption of ventilation…
FDA (openFDA device enforcement)
Reported Apr 18, 2018
Latex Rebreathing Bags: Product Code Equivalent Code (a) 151174050 151174 (b) 153000005 153000005 (c) 153000010…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Teleflex Medical Europe Ltd.
Matched: Brand — These products contain latex, but the following statement is not included on any level of product packaging: Caution: This Product Contains Natural…
3 more products in this recall
FDA (openFDA device enforcement)
Reported Apr 4, 2018
Teleflex MEDICAL WECK Visistat 35. Used for the external skin closure of lacerations.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Teleflex Medical
Matched: Brand · Product · Product details — Some boxes are labeled as Visistat Wide devices, when in fact the contain Visistat Regular devices. The 6 individually packaged units within the…
FDA (openFDA device enforcement)
Reported Mar 7, 2018
Rusch Greenlite MAC 1, Catalog Number 004551001. Used during tracheal intubation.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Teleflex Medical
Matched: Brand — The pouch may contain the incorrect Rusch Green Lite product size. Pouches that are labeled as containing RUSCH GREEN LITE MAC 1 may instead contain…
FDA (openFDA device enforcement)
Reported Nov 15, 2017
WECK(R) from TELEFLEX Auto Endo5(R), Automatic Hem-o-lok(R) Clip Applier, REF AE05ML (IPN010797) Rx ONLY, STERILE EO
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Teleflex Medical
Matched: Brand · Product · Product details — The product has a non-conformity that may cause clips to mislead, jam or fall out of the applier.
FDA (openFDA device enforcement)
Reported Nov 8, 2017
Teleflex(R) Percuvance(TM) Percutaneous Surgical System, Components: (a) 5 mm Atraumatic Johans Grasper, Catalog Number…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Teleflex Medical
Matched: Brand · Product · Product details · Reason for recall — Teleflex is recalling these products because the jaws of the tool tip may break, causing a fragment of the tool tip to fall off during use.
FDA (openFDA device enforcement)
Reported Oct 25, 2017
Pilling Knife Handles: a) REF 352950 b) REF 352953 c) REF 352951 d) REF 352957 e) REF 352952 : Reusable surgical knife…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Teleflex Medical
Matched: Brand — The knife handles slot depth is out of specification, so blades may not fit on the handles properly.
FDA (openFDA device enforcement)
Reported Oct 4, 2017
LMA(TM) MADgic(TM) Laryngo-Tracheal Mucosal Atomization Devices: (a) MAD600 MADgic, (b) MAD700 MADgic, (c) MAD720…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Teleflex Medical
Matched: Brand · Reason for recall — Teleflex Medical is recalling the affected product because there may be missing or incomplete information on the package label.
6 more products in this recall
FDA (openFDA device enforcement)
Reported Jun 21, 2017
Sheridan SHER-I-SLIP and SOFT-TIP Intubating Stylets are intubating stylets manufactured from galvanized carbon steel…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Teleflex Medical
Matched: Brand — Product size listed on the labeling is incorrect.
FDA (openFDA device enforcement)
Reported Jun 14, 2017
Hudson RCI, Pediatric Nasal Cannula, Non-Flared Prongs, Rx only,
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Teleflex Medical
Matched: Brand — Incorrect labeling; the box label indicates Pediatric, the product insert indicates an Adult device.
FDA (openFDA device enforcement)
Reported May 31, 2017
PE CONNECTOR 3/8 STRAIGHT 20/BX, Sterile, Single use, Product Usage: Catheter Connector/Accessory
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Teleflex Medical
Matched: Brand — Labeling: The expiration date is not stated on the labeling, there is a potential for expired product to be used.
3 more products in this recall
FDA (openFDA device enforcement)
Reported May 24, 2017
WECK Visistat 35R Disposable Skin Stapler, Ref 528135, Rx Only, Sterile EO, Visistat is indicated for the external skin…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Teleflex Medical
Matched: Brand — Some boxes are labeled as containing Visistat Wide devices, when they in fact they contained Visistat Regular device.
FDA (openFDA device enforcement)
Reported Apr 26, 2017
Arrow EZ-IO Needle Set 45 mm 15 ga, Ref 9079.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Teleflex Medical
Matched: Brand — Some of the individual unit packaging (pouches) may be missing the lot number an expiration date.
FDA (openFDA device enforcement)
Reported Mar 29, 2017
Teleflex Green Non-Latex Robertazzi Nasopharyngeal Airway, Catalog No. 123130 and 123132 Product Usage: To provide a…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Teleflex Medical
Matched: Brand · Product · Product details — Labeling error
FDA (openFDA device enforcement)
Reported Feb 15, 2017
Sheridan/CF, Cuffed Tracheal Tube, Catalog # 5-10114 and Sheridan/HVT Cuffed Tracheal Tube, Catalog # 5-10315 A…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Teleflex Medical
Matched: Brand — Labeling inconsistency - units labeled with a 7mm tube may contain a size 6.5mm tube, and units labeled 7.5mm tube may contain a size 5.5mm tube.
FDA (openFDA device enforcement)
Reported Dec 28, 2016
LMA MADomizer, Rx only, Product Usage: These products are used for the delivery of topical anesthesia via an atomized…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Teleflex Medical
Matched: Brand · Product details — Product Defect; These products may produce a straight stream instead of a fully atomized plume of medication.
7 more products in this recall
FDA (openFDA device enforcement)
Reported Dec 21, 2016
Weck Facial Closure Systems have application in laparoscopic procedures for approximation of tissues and percutaneous…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Teleflex Medical
Matched: Brand — The devices wings may become partially detached from the EFx Shield during use.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Dec 7, 2016
ARROW OnControl Bone Marrow Biopsy System Tray, Sterile, Rx only, Manufactured for: Teleflex Medical, The Arrow…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Teleflex Medical
Matched: Brand · Product · Product details — Sterility: Due to a potential incomplete seal on the outer sterile package.
4 more products in this recall
FDA (openFDA device enforcement)
Reported Oct 26, 2016
Willy Rusch GmbH Tracheostomy Tube Set Cannulation of tracheotomised patients, particularly in the case of a narrow…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Teleflex Medical
Matched: Brand — The connector may disconnect from the tracheostomy tube during use.
FDA (openFDA device enforcement)
Reported Oct 19, 2016
Teleflex Percuaneous Solutions, Gripper Grasper, Ref ML003EE, Rx Only Sterile Manufactured for: Teleflex Medical, Park,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Teleflex Medical
Matched: Brand · Product · Product details — The product is being recalled due to a labeling error. The Gripper Graspers are labeled as Johans Graspers and the Johans Graspers are labeled as…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Sep 14, 2016
WECK¿ Horizon" Manual-Load Ligating Clip Applier, For Medium-Large Size Horizon Ligation Clips Curved Jaw, 11 (28cm),…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Teleflex Medical
Matched: Brand — Misbranded: Incorrect etching on the device.
FDA (openFDA device enforcement)
Reported Sep 7, 2016
MAQUET Servo Humidifier 163, Inmed Mfg. Sdn. Bhd. Lot PT 2577, Jalan Perusahaan, 4, 34600 Kamunting, Perak, Malaysia.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Teleflex Medical
Matched: Brand — Cracking may occur at the 15mm and 22mm ISO female connector.
FDA (openFDA device enforcement)
Reported Aug 24, 2016
Weck EFx Classic Fascial Closure System, Rx Only, Sterile, The product is intended to facilitate placement and…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Teleflex Medical
Matched: Brand — Incorrect expiration date was printed on the product label.
FDA (openFDA device enforcement)
Reported Aug 17, 2016
Servo Humidifier 163, Model 01-06-8125-8, REF 6419365 Product Usage: A heat and moisture condenser (artifical nose) is…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Teleflex Medical
Matched: Brand — Cracks may occur at the 15mm and 22mm ISO female connector.
FDA (openFDA device enforcement)
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